Exact FDA event identifier

Event 96294

12 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 13, 2025
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Smiths Medical ASD, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

12 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 12

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

Z-1277-2025

Recall number: Z-1277-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 3 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012518, Lot Number 4235595

Distribution pattern

Worldwide distribution.

device · product 2 of 12

smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

Z-1278-2025

Recall number: Z-1278-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 643 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012532, Lot Numbers: 3968088, 4052396, 4063411, 4101698, 4122782, 4219344, 4232319, 4235596, 4242786, 4317072, 4325879, 4397749, 4420759, 4445594, 4449874.

Distribution pattern

Worldwide distribution.

device · product 3 of 12

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24

Z-1279-2025

Recall number: Z-1279-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 2311 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012549, Lot Numbers: 3928188, 3953708, 3957301, 3968097, 3977434, 3988450, 4006475, 4022600, 4027912, 4036893, 4073108, 4086999, 4103105, 4114110, 4122783, 4136362, 4139518, 4152689, 4153871, 4173433, 4189866, 4222392, 4227822, 4235597, 4276226, 4307472, 4317085, 4349806, 4378522, 4387732, 4395511, 4460618, 4434228, 4449233, 4449875, 6013082, 6014983, 4468606, 4426417, 6062037, 6071256.

Distribution pattern

Worldwide distribution.

device · product 4 of 12

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

Z-1280-2025

Recall number: Z-1280-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 9506 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012563, Lot Numbers: 3926121, 3928189, 3953709, 3957303, 4006476, 4008521, 4036894, 4046803, 4096337, 4108664, 4114114, 4114115, 4136363, 4146466, 4153872, 4173601, 4232305, 4235508, 4235598, 4271453, 4291483, 4294059, 4317075, 4317092, 4358052, 4366693, 4366694, 4387733, 4434229, 4449244, 4453603, 4453604, 4453605, 6001912, 6026649, 6051324, 6062012, 6071257, 6077416.

Distribution pattern

Worldwide distribution.

device · product 5 of 12

smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24

Z-1281-2025

Recall number: Z-1281-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 3263 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012594, Lot Numbers: 3926119, 3928191, 3944833, 3960347, 3968098, 3988451, 4027913, 4057817, 4087000, 4139520, 4146467, 4173474, 4196758, 4221725, 4235599, 4256939, 4291484, 4295931, 4302979, 4307473, 4307474, 4437254, 4447572, 4449876, 4460619, 6037144, 6006017, 6059285, 6026682, 6062025, 6071258.

Distribution pattern

Worldwide distribution.

device · product 6 of 12

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24

Z-1282-2025

Recall number: Z-1282-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 1695 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012686, Lot Numbers: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, 6003890.

Distribution pattern

Worldwide distribution.

device · product 7 of 12

smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24

Z-1283-2025

Recall number: Z-1283-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 1961 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012716, Lot Numbers: 3941279, 3969275, 3984421, 4022601, 4136364, 4148590, 4153873, 4196768, 4227788, 4232310, 4235600, 4248718, 4276227, 4302980, 4307478, 4317093, 4325880, 4358053, 4358054, 4395512, 4415445, 4420760, 4437255, 4449234, 4449877, 4460620, 6013083, 6003891, 6053532, 6062026.

Distribution pattern

Worldwide distribution.

device · product 8 of 12

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24

Z-1284-2025

Recall number: Z-1284-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 1 unit

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012723, Lot Numbers: 4235509

Distribution pattern

Worldwide distribution.

device · product 9 of 12

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

Z-1285-2025

Recall number: Z-1285-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 12 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012747, Lot Numbers: 4317077

Distribution pattern

Worldwide distribution.

device · product 10 of 12

smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24

Z-1286-2025

Recall number: Z-1286-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 0 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012754, Lot Numbers: 4196769

Distribution pattern

Worldwide distribution.

device · product 11 of 12

smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24

Z-1287-2025

Recall number: Z-1287-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 8515 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012778, Lot Numbers: 3916028, 3969277, 4006477, 4022602, 4036895, 4057818, 4060894, 4096338, 4108453, 4114117, 4146468, 4153874, 4163556, 4196775, 4221727, 4235565, 4235567, 4235601, 4248694, 4256927, 4256928, 4256964, 4276228, 4294894, 4294895, 4364693, 4366695, 4366696, 4378523, 4382349, 4392370, 4395513, 4405010, 4420761, 4426418, 4434230, 4453606, 4468579, 4468580, 6005957, 6005958, 6026650, 6026651, 6037122, 6037124, 6051325.

Distribution pattern

Worldwide distribution.

device · product 12 of 12

smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

Z-1288-2025

Recall number: Z-1288-2025
Initiated: February 13, 2025
Classification: Class I
Status: Ongoing
Recalling firm: Smiths Medical ASD, Inc.
Quantity: 2236 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Code information

UDI/DI 10610586012839, Lot Numbers: 3906623, 3922514, 4120026, 4152690, 4157409, 4196736, 4227806, 4264408, 4271442, 4317086, 4337691, 4382350, 4387734, 4405011, 4440712, 4445592, 4460621, 4468591, 6013085, 6026683, 6037136, 6051319, 6071259.

Distribution pattern

Worldwide distribution.